The Westport, Connecticut-based company will sponsor a research agreement with the Cleveland Clinic Foundation to investigate expanded clinical applications for the intracardiac signals that are acquired by its Pure EP system. Through the agreement, Cleveland Clinic will conduct physician-initiated scientific research investigating Pure EP potential to address common limitations of signal processing and signal use expansion during electrophysiology ablation procedures.
Cleveland Clinic was selected as the research partner based on its world-class physician faculty, research competency and mutual interest in using digital signal processing technology to advance the field of cardiac electrophysiology.
“As a non-profit, research, education, and healthcare institution, Cleveland Clinic has a long legacy of innovation in cardiovascular disease, and specifically in the field of electrophysiology. At BioSig, we embody their commitment to clinical discovery and ensuring that optimal treatments are made available to patients with efficiency and efficacy,” BioSig Chief Commercial Officer Gray Fleming said in a news release. “We are honored to align ourselves with Cleveland Clinic’s expertise as we discover new ways to positively impact procedural workflows by leveraging digital signal processing technology.”
Pure EP is an FDA 510(k) cleared non-invasive device that is designed to drive procedural efficiency in cardiac electrophysiology, according to BioSig Technologies. It is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. Clinical data results from a multi-center study of Pure EP showed 93% consensus across blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting Pure EP signals over conventional sources.